Medical Device Enforcement Data Shows Rise In Violations

The U.S. Food and Drug Administration (FDA) has released enforcement data from a three-year period that details trends in its inspections of medical device manufacturing plants. It shows a sharp rise in violations and a disproportionate number of production slip-ups in foreign countries. According to regulators at the FDA’s Center for Devices and Radiological Health, they unveiled the information from inspections in 2010-2012 as part of a transparency initiative. Their hope was that it would result in improved product quality and companies avoiding warning letters that can require costly responses.

The raw number of inspections jumped more than 35 percent in that time period, and the number of inspections on foreign soil rose more than 90 percent, according to the FDA. Foreign firms were targeted in about 10 percent of the FDA’s roughly 2,750 inspections, but they accounted for more than 30 percent of inspections where significant violations were discovered, and they were the targets of 40 percent of warning letters for such missteps, the agency reported.

Of the 164 quality-related warning letters issued in 2012, 66 went to non-U.S. companies, with one third of that discipline targeting Chinese firms. The total number of warning letters was up sharply from 122 in 2011 and 89 in 2010, a trend the FDA attributed to the increased frequency of inspections as well as “increased focus on foreign firms by the foreign device cadre and improved site selection.” The FDA supplemented those high-level findings with an abundance of granular detail about categories of violations and the specific regulatory provisions to which they related. For example, when the FDA finds objectionable manufacturing conditions, it issues a so-called 483 report that lists the violations.

In 2012, those reports included about 4,250 total violations. Of those violations, 30 percent were related to shortcomings involving so-called corrective and preventive actions – formalized policies related to quality control. Another 30 percent concerned so-called production and process controls, which relate to ensuring a product meets its design specifications. The rest of the violations were divided in fairly equal amounts among three other categories: management oversight, special restrictions that apply to riskier devices, and record-keeping.